Peripherally Inserted Central Catheter
FDA 510(k) K001874 · Utah Medical Products, Inc.
510(k) numberK001874
Submission
- Device name
- Peripherally Inserted Central Catheter
- Applicant
- Utah Medical Products, Inc.
Midvale, UT, US - Received
- June 20, 2000
- Decision date
- September 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260929 | Neonav ECG Tip Location SystemLJS · Special | Navi Medical Technologies | 04/17/2026SE |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…LJS · Traditional | Spectrum Vascular | 12/16/2025SE |
| K252792 | PM2 System with ECGuide ConnectorLJS · Special | Piccolo Medical, Inc. | 11/17/2025SE |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional | Access Vascular, Inc. | 08/01/2025SE |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special | Access Vascular, Inc. | 07/01/2025SE |
| K243484 | PM2+ System and SmartPICC StyletLJS · Traditional | Piccolo Medical, Inc. | 05/29/2025SE |
| K241587 | pilot TLSLJS · Traditional | Vygon Corporation | 02/26/2025SE |
| K241910 | Neonav ECG Tip Location SystemLJS · Traditional | Navi Medical Technologies | 01/19/2025SE |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special | Access Vascular, Inc. | 01/17/2025SE |
| K240486 | PM2 System and ECGuide ConnectorLJS · Traditional | Piccolo Medical, Inc. | 09/08/2024SE |
More from Piccolo Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K143424 | Utah Cvx-RipePFJ · Traditional | 08/28/2015SE |
| K123310 | Finesse 3RD Generation (Models Finesse+ and Finesseii+)GEI · Traditional | 01/23/2013SE |
| K101535 | Bt-CathOQY · Traditional | 01/11/2011SE |
| K063611 | Saline/ Contrast Media Infusion CatheterLKF · Traditional | 05/23/2007SE |
| K000974 | Fowler Endocurette, Model Cur-XxxHHK · Traditional | 05/23/2000SE |
| K965245 | TBDHGI · Traditional | 07/03/1997SE |
| K970077 | Liberty Plus SYSTEM(PFS-300)/VAGINAL Probe, Liberty PLUS(PFS-044)KPI · Traditional | 05/23/1997SE |
| K955663 | Abc In-Line Blood Sampling KitCBT · Traditional | 03/17/1997SE |
| K964526 | Liberty Rectal Pelvic Floor ExerciserKPI · Traditional | 02/10/1997SE |
| K961424 | Intran 500HFN · Traditional | 07/10/1996SE |
Questions and answers
When was Peripherally Inserted Central Catheter cleared by the FDA?
Peripherally Inserted Central Catheter (K001874) received a 510(k) decision of Substantially Equivalent on September 25, 2000, 97 days after the submission was received.
What is the product code of K001874?
The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.